An Open-Label Pharmacodynamic Study of Bevacivumab and Pazopanib in Renal Cell Carcinoma

Sponsor
GlaxoSmithKline
Study ID
NCT00992121
Phase
PHASE1
Status
Completed

Conditions

  • Carcinoma, Renal Cell

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Bevacizumab — DRUG
    Bevacizumab - 3 infusions of 10mg/kg administered at 2 week intervals - Part I
  • Pazopanib 2 week — DRUG
    Pazopanib for first 2 weeks of each 3-week cycles as follows: 1) 200 mg twice weekly, 2) 200 mg every other day, 3) 200 mg qd, 4) 400 mg qd, 5) 800 mg qd, and 6) 1200 mg qd (Group 1). Maintenance pazopanib 800 mg qd for all 3 weeks throughout repeating 3-week cycles. Number of cycles: until death, loss of clinical benefit, unacceptable toxicity, or withdrawal from the study for other reasons.
  • Pazopanib 3 week — DRUG
    Pazopanib throughout each 3-week cycle as follows: 1) 200 mg twice weekly, 2) 200 mg every other day, 3) 200 mg qd, 4) 400 mg qd, 5) 800 mg qd, and 6) 1200 mg qd (Group 1). Maintenance pazopanib 800 mg qd for all 3 weeks throughout repeating 3-week cycles. Number of cycles: until death, loss of clinical benefit, unacceptable toxicity, or withdrawal from the study for other reasons.

Study Details

This study will determine whether blood tests, tumour imaging and tumour tissue analysis can reveal effects of drugs that block blood vessel growth (angiogenesis) in patients with renal cancer.

Key Dates

First listed
Oct 9, 2009
Start date
Nov 18, 2009
Status verified
Nov 2017
Primary completion
Nov 1, 2013
Completion
Nov 1, 2013

Study Design

Enrollment
11 participants (actual)
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
OTHER

Arms

  • Other: Part I and 2 week dosing Part II
    Part I - bevacizumab 3 infusions at 2 week intervals Part II - pazopanib dosing 2 weeks in 3-week cycles
  • Other: Part I and 3 week dosing Part II
    Part I - bevacizumab 3 infusions at 2 week interval, Part II - pazopanib dosing 3 weeks in 3-week cycles

Primary Outcome Measure

Tumour size, as measured by the sum of the longest diameters of all target lesions on CT [ Time Frame: 6 weeks ]

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